Single Cell Sequencing Analysis of Thymoma | NCT04162691

Studies
Single Cell Sequencing Analysis of Thymoma

NCT04162691

Sponsor

Zhejiang Cancer Hospital

Status

Unknown status

Last Update Posted

Jan 13, 2023Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Thymoma

Interventions

Tissue

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 6, 2020Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 6, 2019

First Submission Date that Met QC Criteria

Nov 11, 2019

First Posted Date

Nov 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2023

Last Update Posted Date

Jan 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to understand how genetics play a role in thymoma. Intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. However, developments in high-throughput single-cell RNA sequencing (scRNA-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. This study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to Benign thymoma, at a single-cell level using a flow cytometry and RNA-sequencing protocol.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Malignant thymoma			Diagnostic Test: Tissue
Benign thymoma			Diagnostic Test: Tissue

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue	Diagnostic Test	Four 4-5 mm tissues of the thymoma	Benign thymoma Malignant thymoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determination of cell population from thymoma	The genes expression and the cell population	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with thymoma
Ability to provide written consent and comply with the protocol
At least 18 years of age

Exclusion Criteria:

Patients undergoing thymoma treatment
Patients with previous malignancy
Known HIV positive status.
Evidence of abnormality of any immune cell population from a drug-induced or genetic cause.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients referred to the clinic for investigation of a suspected thymoma condition

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
An ZHAO, MD, PHD	Contact	8688122413		zhaoan@zjcc.org.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
An Zhao	Recruiting	Hangzhou		310022	China

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no plan to make individual participant data (IPD) available to other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013945	Thymoma

Ancestor Terms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D013953	Thymus Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006650	Histocompatibility Testing

Ancestor Terms

ID	Term
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided